临床药物治疗杂志
臨床藥物治療雜誌
림상약물치료잡지
CLINICAL MEDICATION JOURNAL
2014年
3期
43-48
,共6页
张婷%李灿%林京玉%邢丽秋%贾国强%张黎明%赵荣生
張婷%李燦%林京玉%邢麗鞦%賈國彊%張黎明%趙榮生
장정%리찬%림경옥%형려추%가국강%장려명%조영생
碘海醇%不良反应%安全性评价%风险管理
碘海醇%不良反應%安全性評價%風險管理
전해순%불량반응%안전성평개%풍험관리
lohexol injection%safety evaluation,risk management%adverse drug reaction
目的：评价碘海醇注射液的临床总体安全性，分析碘海醇致不良反应发生的规律和特点，提出碘海醇注射液临床使用的风险管理建议。方法：对比分析碘海醇注射液的国内外药品说明书，汇总评价北京市药品不良反应监测中心数据库中近5年碘海醇注射液药品不良反应报告，制定碘海醇临床使用的风险管理策略。结果：经评价，国内外不同厂家碘海醇注射液的说明书存在明显差异，尤其是不良反应方面。在212例碘海醇注射液不良反应报告中，老年人不良反应的发生率较高，主要累及皮肤及附件、循环系统、消化系统等，其中皮肤及附件的损害最常见，占57.1%，主要表现为皮疹、荨麻疹和瘙痒等。严重不良反应为过敏性休克、肾功能异常等。结论：碘海醇注射液是临床应用广泛的非离子型造影剂，不良反应较明确。应通过加强医院层面的行政干预和宣传教育等措施，规范碘海醇注射液的操作流程，提倡多科室合作的用药监护，保障碘海醇注射液的临床用药安全。
目的：評價碘海醇註射液的臨床總體安全性，分析碘海醇緻不良反應髮生的規律和特點，提齣碘海醇註射液臨床使用的風險管理建議。方法：對比分析碘海醇註射液的國內外藥品說明書，彙總評價北京市藥品不良反應鑑測中心數據庫中近5年碘海醇註射液藥品不良反應報告，製定碘海醇臨床使用的風險管理策略。結果：經評價，國內外不同廠傢碘海醇註射液的說明書存在明顯差異，尤其是不良反應方麵。在212例碘海醇註射液不良反應報告中，老年人不良反應的髮生率較高，主要纍及皮膚及附件、循環繫統、消化繫統等，其中皮膚及附件的損害最常見，佔57.1%，主要錶現為皮疹、蕁痳疹和瘙癢等。嚴重不良反應為過敏性休剋、腎功能異常等。結論：碘海醇註射液是臨床應用廣汎的非離子型造影劑，不良反應較明確。應通過加彊醫院層麵的行政榦預和宣傳教育等措施，規範碘海醇註射液的操作流程，提倡多科室閤作的用藥鑑護，保障碘海醇註射液的臨床用藥安全。
목적：평개전해순주사액적림상총체안전성，분석전해순치불량반응발생적규률화특점，제출전해순주사액림상사용적풍험관리건의。방법：대비분석전해순주사액적국내외약품설명서，회총평개북경시약품불량반응감측중심수거고중근5년전해순주사액약품불량반응보고，제정전해순림상사용적풍험관리책략。결과：경평개，국내외불동엄가전해순주사액적설명서존재명현차이，우기시불량반응방면。재212례전해순주사액불량반응보고중，노년인불량반응적발생솔교고，주요루급피부급부건、순배계통、소화계통등，기중피부급부건적손해최상견，점57.1%，주요표현위피진、담마진화소양등。엄중불량반응위과민성휴극、신공능이상등。결론：전해순주사액시림상응용엄범적비리자형조영제，불량반응교명학。응통과가강의원층면적행정간예화선전교육등조시，규범전해순주사액적조작류정，제창다과실합작적용약감호，보장전해순주사액적림상용약안전。
Objective: To assess overall clinical safety of iohexol injection, analyze the laws and characteristics of the adverse drug reaction (ADR), and propose advices on the risk management strategy. Methods: The Chinese and American drug labels of iohexol injection were compared. Beijing Adverse Drug Reactions Monitoring Network database in recent five years was searched and analyzed for ADR reports of iohexol injection. The risk management strategy of iohexol injection was established. Results: Through this assessment, it has been found that there were obvious differences among Chinese and American drug labels, especial y in the sector of ADR information. A total of 212 reports were col ected, and the ADRs occurred more often in senile patients. The ADRs were implicated in some organs and systems, and the most common ADRs were observed in skin and appendix (57.1%) with clinical manifestation including rash, urticaria and itching, fol owing by circulation system and digestive system. The anaphylactic shock and abnormal renal function were the most commonly observed serious ADRs. Conclusion: Iohexol injection is a widely used non-ionic contrast agent with relatively clear ADRs. The goal of clinical safey of Iohexol injection can be achieved by hospital-level administrative intervention and education for healthcare providers, standardization of operation procedures and col aboration on monitoring among different departments.
